Regulators participating in the International Medical Device Regulators Forum (IMDRF) recently convened in Tokyo to discuss a medical device single review program (MDSRP).
The meeting involved the IMDRF good regulatory review practices (GRRP) working group, which took up
medical device premarket reviews as a new work item after the September 2018 management committee meeting in Beijing. An “important document” for MDSRP was discussed and “unanimously recognized” by the participants, according
to China’s Center for Medical Device Evaluation (CMDE).
The new document titled the “Recognition Requirements and Procedures for Pre-marketing Evaluation of Medical Devices” relates to the third-party evaluation organizations that would be needed to pursue MDSRP. IMDRF member countries include the US, Europe, Canada, Australia, Singapore, Japan, China, South Korea, Russia and Brazil—all of which have different approaches to premarket evaluations. MDSRP would be a major undertaking for IMDRF, though it has been years in the making.
Interest in a program like MDSRP involves earlier patient access to devices across multiple jurisdictions, which would rely in whole or in part on submissions for approvals or clearances. Industry implications relate to the potential cost savings and reduced regulatory burden that could be achieved through a program like MDSRP. The potential risk to user health, however, would also be introduced on a larger scale.
The GRRP working group developed the IMDRF proposed document from 2016 on competence, training and conduct requirements that is intended to serve as a tool for a consistent, harmonized approach to device evaluation among regulatory authorities or designated conformity assessment bodies. This IMDRF document has yet to be finalized, but a string of other documents that would also play a role in MDSRP were finalized last year. These relate to essential principles of safety and performance, the IMDRF Table of Content (ToC) structure and the regulatory product submission (RPS) beta testing report.
Further, CMDE reported that the GRRP working group agreed to the July 2018 proposed document
on device labeling principles while in Tokyo. CMDE representatives at the December 2018 meeting “attached great importance” to the new IMDRF document on recognition requirements and procedures and proposed options for information sharing, feedback mechanisms, scalability and MDSRP testing. It was the “first time that the IMDRF China working group went to a face-to-face meeting,” CMDE said.
Still, the US Food and Drug Administration (FDA) has been entertaining the MDSRP concept over the past few years. An FDA meeting
in 2016 on the Medical Device User Fee Amendments of 2017
(MDUFA IV) discussed the agency’s version of an industry proposal for MDUFA improvements, which included funding to assess harmonizing its third-party premarket review program with a program like MDSRP.
It was later decided that FDA would work with industry to “enable the development of a broader successful” third-party review program under the finalized MDUFA commitment letter
. The agency proposed a new framework to leverage the Medical Device Single Audit Program (MDSAP) as part of its pledge to strengthen its third-party review program via draft guidance issued
ast September. MDSAP—a cornerstone of IMDRF—is already set to serve as a model for the phased-in implementation of MDSRP.
The conformity assessment and recognition program that was still under IMDRF consideration at the meeting last September would be a program to be modeled after MDSAP “by leveraging existing documents where possible and making modifications as necessary to accommodate MDSRP requirements,” according
to the update from the FDA-led GRRP working group. The MDSRP version of the program was the subject of the new document discussed and “unanimously recognized” during the GRRP meeting last December.
“MDSRP is a new work item proposal under consideration by the [IMDRF] management committee and was discussed during the December GRRP working group meeting in Tokyo,” Lena Cordie, president and founder of medical device consulting firm Qualitas Professional Services, confirmed with Focus
Details on the work led by FDA’s Center for Devices and Radiological Health (CDRH) around MDSRP’s development began to trickle out last September when CDRH Director Jeff Shuren indicated
that the program would be rolled out “in the next few years” as IMDRF had agreed to set up the building blocks.
With the decision for Singapore to co-chair the premarket review effort with the US, Shuren later reported
MDSRP would be similar to MDSAP in that the program would be first piloted in some IMDRF jurisdictions. He also noted that some IMDRF countries were already on board to be MDSRP pioneers.
Yet a number of barriers remain, including the project jointly funded by FDA and industry to establish a National Evaluation System for health Technology (NEST). NEST is reportedly
hinging on approving the $46 million FDA requested under the president’s budget for fiscal year 2019.
NEST will be “fundamental” for establishing MDSRP and to “create a ‘global passport’ for worldwide patient access to safe and effective devices,” Shuren argued
during an October 2018 meeting at FDA’s White Oak campus. Other challenges relate to the ToC structure not being widely adopted across IMDRF member countries and inconsistencies in the adoption of other IMDRF programs, including MDSAP